Stomach probe

ABSTRACT

The invention is based on the intention of creating a stomach probe with which a watertight closure of the oesophagus is possible. The stomach probe, according to the invention, is characterized by a tampon-bladder for watertight closure of the oesophagus, in which the tampon-bladder forms from flexible and/or elastic material at least a closed inner cavity for the reception of a fluid medium, through a means ( 11 ) of establishing a prescribed pressure for the medium in the tampon-bladder ( 16 ) by an inner lumen forming the actual stomach probe, from which an outer hose-like lumen ( 18 ) extending to the tampon-bladder ( 16 ) is so arranged that between the outer lumen ( 18 ) and the inner lumen ( 17 ) a channel is formed connected to the inner cavity of the tampon-bladder ( 16 ) arranged on the outer lumen ( 18 ) by a number of openings ( 20 ), whereby the inner cavity of the tampon-bladder ( 16 ) is connected via the canal formed between the inner and outer lumina ( 17, 18 ) with the means of production of pressure in the tampon-bladder, that is, with a suitably graded reservoir or equalizing vessel ( 11 ) for the liquid medium situated above the tampon-bladder and outside the patient.

[0001] Material rising up into the pharynx from the stomach andintestinal tract represents, particularly for the unconscious patientbeing ventilated, a permanent reservoir of microbes, and may provoke orexacerbate pulmonary infection from the lower pharynx on intubation.Artificially ventilated intensive care patients are looked after throughsecretion-stimulating gastric probes or feeding tubes whose throughputas a rule is still insufficient to put a stop togastro-oesophogeo-pharyngeal reflux beside or along them. As a resultthe greater number of sedated or artificially ventilated patients arevirtually overwhelmed by high-grade bacterially contaminated material inthe pharyngeal, nasal and postnasal regions.

[0002] On account of various difficulties in the search for a simplemechanical oesophageal or gastric blockade tolerable in the long termthis infective problem potential could not until now be satisfactorilyresolved. What was tried out therapeutically, and generally tolerated,was essentially medicinal/antibiotic (e.g. selective boweldecontamination).

[0003] Since the structures of the oesophageal wall react extremelysensitively to persistent pressure or tension, the conventional blockingtechniques, in which the walls of the attached structures are placedunder tension (as a rule by a balloon) are not, or only withlimitations, applicable in the case of the oesophagus.

[0004] The purpose of the invention is to rectify the disadvantages justmentioned and to present a stomach probe with which closing off orfilling out of the oesophagus is possible without deleterious effect onits wall structures.

[0005] For the resolution of this aim the stomach probe is equipped withthe characteristics of Patent claim 1.

[0006] The oesophagus is a dynamic structure constantly changing inshape. The tonus of its wall, and its lumen, are subject to considerableactive and passive functional fluctuations. Tamponization of theoesophagus by a bladder like that of the invention fits in with theirphysiological dynamic and thus guarantees a simple self-regulating andwell-tolerated closure or filling of the gullet. Regurgitation ofmaterial highly contaminated with microbes from the stomach and gutregions into the oral, nasal or pharyngeal cavities is prevented by theinvention. By means of the invention gastro-oesophageal-pharyngealreflux is prevented by a simple self-regulating and well-toleratedmechanical blockade in the oesophageal region. Drainage of stomachcontents is thus guaranteed to take place through an ordinary stomach orfeeding probe.

[0007] Ulcerations or necroses of the oesophageal wall structures as aresult of long-term blocking are excluded by the most far-reachingpressure-passive actions of the tampon-bladder described in theinvention.

[0008] Immediately adjoining structures such as the great vessels, theaccompanying nerves, the trachea and main bronchi, the lungs themselvesand, not least, the heart, particularly the left atrium, are, incontrast to conventional blocking, not endangered.

[0009] The inner cavity of the tampon-bladder may be filled with themedium, through a channel lying between the inner and outer lumina, froma filling device connected to the channel. Simply operated examples ofsuch a filling device are a reservoir or equalizing vessel, particularlyone situated outside the patient. A supply of the medium sufficient tofill the inner cavity of the tampon-bladder, and in addition to allowfor the abovementioned functional fluctuations of the lumen and thetonus of the oesophageal wall through further outflow or intake of themedium by expansion and collapse of the tampon-bladder, is kept in thereservoir or equalizing vessel.

[0010] In this connection it could be seen as an additional advantagefor the medium to be actively led into the inner cavity of thetampon-bladder or withdrawn from the inner cavity through the channel.Such active supply and withdrawal take place through a pump which isregulated preferably to compensate for any extensive pressure-passivefluctuations in the tampon-bladder.

[0011] So that a medium is used which can be supplied or withdrawnrapidly and at the same time has a thermal capacity high enough for theadjustment of the temperature measured inside the oesophagus, it can bea fluid such as for example water or equivalent. Such a medium is simpleand quick to pump and easily adjustable in temperature.

[0012] Another medium which is distinguished by compressibility as wellas a certain adaptability of its own to the fluctuations mentioned aboveis, for instance, a gaseous one. Filling apparatus, reservoir,equalizing vessel and pump may all be used with any suitable medium andare designed accordingly.

[0013] Further advantageous embodiments of the invention derive fromfeatures in the Claims below.

[0014] The invention is more precisely explained with the help of thefollowing Figures as operational examples:

[0015]FIG. 1 a frontal view of the oesophagus (gullet) with adjoininganatomical structures. Also shown is the combination of stomach probeand tampon-bladder shown subsequently;

[0016]FIG. 2 the construction of the device, with stomach probe,tampon-balloon, wide-bore connection and extracorporeal reservoir in arecommended operational form of the invention;

[0017]FIG. 3 a section of the line 1-1 of FIG. 2;

[0018]FIG. 4 a simplified representation of a section through the wallof a further possible operational form for the tampon-bladder of thestomach probe;

[0019]FIG. 5 a ball-shaped pressure-container manufactured from anelastic material, e.g. rubber, for use with the stomach probe of FIGS.1-3 in place of the open reservoir;

[0020]FIG. 6 a simplified representation of a stomach probe with apressure-measuring system;

[0021]FIG. 7 a simplified representation of a signal from thepressure-sensor led off and shown as a diagram on a screen;

[0022] In FIG. 1 is shown the topographical relation to the relevantadjoining anatomical structures (trachea and main bronchi and greatarterial vessels) of the correctly-placed apparatus or stomach probe 17,consisting of a hose-like probe element or lumen 17′ with tampon-bladder16. As indicated, a tampon-bladder 16 about 15 to 20 cm long and filledwith water or another suitable medium is positioned in the vicinity ofthe middle third of the oesophagus. Through the tampon-bladder 16 runthe regular feeding-tube or stomach probe and the lumen 17′, that cometo lie with the lower end 17 b in the stomach, and the upper end 17 acontrolled orally or nasally. This way enteral feeding and the drainageof stomach and gut secretion are guaranteed.

[0023] The tampon-balloon 16, filled with water or another suitablemedium, communicates via a second, concentric, outer lumen of thegreatest possible diameter with an extracorporeal reservoir 11. In FIG.1 this tampon-balloon is indicated by cross-hatching.

[0024] In FIG. 2 the principle of the entire apparatus, consisting ofthe probe or probe-hose 17′ and tampon-bladder 16, is shown in moredetail. The stomach-probe 17 is surrounded in the region of thetampon-bladder 16, as well as in the sector of the apparatus extendingfrom the tampon-bladder to the extracorporeally placed reservoir 11, bya concentrically arranged outer lumen 18. This lumen, for choice aslarge as possible, permits a rapid to-and-fro exchange of fluid betweenthe tampon-bladder 16 and reservoir 11. On the principle ofcommunicating pipes the outer lumen 18 is responsible for a continuousshape-maintaining self-regulating filling of the tampon-balloon 16,without thereby putting the wall of the oesophagus under any notabledegree of stress. The tamponade of the gullet can thus be maintainedwith a minimal continually sustained pressure to keep up the filling. Atthe same time the outer lumen 18 is shored up by bridge-like structuresor dividing fixtures 19 between the outer and inner walls of the probe.

[0025] In the region 16 a to 16 b enclosed by the tampon-balloon 16, thewall of the outer lumen 18 of the concentric probe, which has twolumina, is perforated 20 like a sieve. When in the act of swallowing orvomiting a wave of contraction of the oesophagus directed towards eitherthe stomach or the pharynx ensues, the perforations in the outer wall ofthe probe permit a shift of volume from the tampon-bladder 16 into theouter lumen 18 of the probe, and consequently a rapid exchange of volumebetween contracted and ready but relaxed sectors of the probe. Thesieve-like construction of the outer lumen of the probe thus makes rapidredistribution of balloon-filling inside the tampon-bladder readilypossible and so puts up a slight to overwhelming resistance against acontraction wave being transmitted by the act of swallowing at a speedof about 2-3 cm/second. Greater shifts of volume, which cannot be evenedout immediately inside the tampon-bladder, are possibly transmitted awayto the extracorporeal reservoir 11. The reservoir 11 is situated outsideand above the patient and takes the form of a graduated water-column.The probe 17 and its constituents 17′, 16 and 18 are constructed of abody-tolerated sufficiently elastic material, like that already used forordinary feeding-probes.

[0026] The tampon-bladder 16 is constructed from an equallybody-tolerated foil-like elastic material, which follows the changes ofthe oesophagus in form and volume without wrinkling, and clings to itsepithelium. It is preferably a body-tolerated soft foil with propertiesresembling those of latex skin. The connection between thetampon-bladder 16 and the lumen 17′ at 16 a and 16 b is brought about byadhesion, welding and adhesion, bandaging or something similar.

[0027] To ensure correct placing of the apparatus and its tampon-bladderin the oesophagus, the apparatus is distinguished by a coloured markercorresponding to its later position at the corner of the mouth withoral, or at the nostril with nasal, insertion.

[0028] With use of the reservoir 11 the water-pressure in thetampon-bladder 16 is decided solely by the column of water reaching tothe reservoir 11, so that the reservoir 11 has a level slightly abovethe tampon-bladder 16. In this way a very constant inner pressure, lyingmarginally above the atmospheric, is maintained in the tampon-bladder16.

[0029]FIG. 4 shows in very simplified representation a section throughthe tampon-bladder 16 a in a further possible operational form of theinvention. The wall 21 of this tampon-bladder is made of a very thinflexible material (foil) and on the inside of the tampon-bladder 16 aforms many persistent folds 22. To these folds 22 the material formingthe wall 21 for instance is suitably adherent or otherwise affixed, sothat on expansion of the inner cavity of the tampon-bladder 16 a byslight pressure the folds open out and consequently can press thetampon-bladder 16 a with its wall 22 closely to the wall of theoesophagus, and in fact to a variety of anatomical situations.

[0030] It can be assumed that in the system described in the context ofFIGS. 1-3 the pressure inside the tampon-bladder 16, lying slightlyabove atmospheric pressure, is set by the fluid- or water-column withthe help of the open, extracorporeal reservoir 11.

[0031]FIG. 6 shows a closed reservoir 23, ball-shaped and made out of anelastic material such as rubber. The inner cavity of the reservoir 23 isconnected via the large-diameter connecting hose 24 with the outer lumen18 of the otherwise not further represented stomach probe. In additionthe reservoir 23 has a plug-like stopper 25, through which filling withwater can be done, in fact in such a way that the whole system, namelythe tampon-bladder 16 or 16′, the lumen 18, the connecting hose 24 andthe reservoir 23 are completely filled with water. Filling follows up toa limited pressure, in fact the kind that comes from the elasticproperties of the wall of reservoir 23, and the requisite limitedpressure ensues. To reach the desired pressure an optical marker 26 isplaced on the outer surface of the reservoir wall 23, in fact delineatedin such a way that on account of the elastic stretching of the wall ofthe reservoir 23 at the correct pressure this symbol 26 takes on aneasily perceptible symmetrical shape. In the operational form shown thesymbol 26 is a quadrilateral of which the corner points form the cornerpoints of a square whose sides appear concave on the outside ofunpressurized reservoir 23, so that on increasing pressure in thereservoir this marker 26 assumes the form of a square.

[0032] Other shapes are also conceivable for the symbol 26, for instancean oval closed line which with the correct inner pressure of thereservoir 23 changes to a circular shape, etc.

[0033] Consequently with the help of the symbol 26 the inner pressure ofthe tampon-bladder 16 or 16′ can of course also be brought to a pressurelying slightly above atmospheric pressure. The closed system with thereservoir 23 has the advantage that this reservoir can be placed forinstance on a divan or bed beside the head of the patient.

[0034]FIG. 6 shows the stomach probe of FIG. 2 once again in simplifiedform. A small thin measuring tube is shown as 27, which at its one,open, end 27′ is located in the region of lumen 18 surrounded by thetampon-bladder 16, in fact in the vicinity of the openings or apertures20. The other end of the measuring tube 27 leads off the outer lumen 18and hence off the connecting hose 24, and is shown in FIG. 5 as 27″. Atthis 27″ end is located a pressure gauge 28 which converts the pressureinside the measuring tube into an electrical signal proportionate to thepressure. The pressure gauge 28 is connected through a measuring-lead toamong others an electronic device 31 showing a screen 30, which may forexample be that of a calculator or PC. The interior of themeasuring-tube 27 is completely filled with the fluid (water), so thatthe pressure exerted in the outer lumen in the region of thetampon-bladder 16 or 16′ appears immediately, that is to say as far aspossible without delay, on the pressure-gauge 28. With this measuringapparatus intrathoracic pressures or changes in pressure can be measuredwithout problems, particularly the mobility of the oesophagus, therespiration and also the atrial and ventricular actions of the heart. Inparticular the depth of anaesthesia can also be determined in a patientunder anaesthesia. The measuring-tube 27 and the pressure-gauge form themeasuring-probe 32.

[0035] The pressure determined with the measuring-probe 32 can beassessed in various ways and/or be shown on the screen. For example anindication can be given in the diagram reproduced in FIG. 7, in whichthe pressure is depicted on the abscissa and the first succession oftemporal pressure changes on the ordinate. By this means a persistentcluster of curves from the curves 33 enclosed in it is produced in thevisible region of the screen, by which the time component of thiscluster of curves is taken into consideration by means of distinguishingcolouration, that is, by alternation of colours at settled timeintervals.

Key to Illustrations

[0036]11 Reservoir

[0037]16, 16′ Tampon-bladder

[0038]16 a, 16 b End of tampon-bladder

[0039]17 Stomach probe

[0040]17′, 18 Lumen

[0041]19 Divider

[0042]20 Opening

[0043]21 Wall

[0044]22 Fold

[0045]23 Reservoir

[0046]24 Connecting hose

[0047]25 Stopper

[0048]26 Marker

[0049]27 Measuring tube

[0050]27′, 27″ End

[0051]28 Sensor or Pressure-gauge

[0052]29 Measuring lead

[0053]30 Screen

[0054]31 Electronic measuring device

[0055]32 Measuring probe

[0056]33 Curve (of graph)

1. Stomach probe, characterized by a tampon-bladder (16) for the closingor filling out of the oesophagus, in which the tampon-bladder (16) offlexible and/or elastic material forms at least one inner cavity, closedto the exterior, for the reception of a medium, an inner lumen(17′)forming the actual probe relative to which an outer lumen (18)extending to the tampon-bladder (16) is so placed that between the outerlumen (18) and the inner lumen (17′) at least one channel is formed,communicating through at least one opening (20) with the inner cavity ofthe tampon-bladder (16) situated on the outer lumen (18) wherein theinner cavity of the tampon-bladder (16) can be filled from a fillingdevice (11, 23) by the channel formed between the inner and outer luminaand connectable to the channel.
 2. Stomach probe according to claim 1 ,characterized in that the filling apparatus is a reservoir or equalizingdevice (11, 23)for the medium, placed outside the patient.
 3. Stomachprobe according to claim 1 or 2 , characterized in that the fillingapparatus is a pump, particularly a regulatable pump.
 4. Stomach probeaccording to at least one of the foregoing claims, characterized in thatthe medium is a fluid.
 5. Stomach probe according to at least one of theforegoing claims, characterized in that the medium is gaseous. 6.Stomach probe according to at least one of the foregoing claims,characterized in that the outer lumen(18) is arranged in a hose-likemanner on the inner lumen (17).
 7. Stomach probe according to at leastone of the foregoing claims, characterized in that the reservoir orequalizing device (11, 23) forms a means for the adjustment of aprescribed pressure in the tampon-bladder (16).
 8. Stomach probeaccording to at least one of the foregoing claims, characterized in thatthe reservoir or equalizing device (11, 23) is graduated.
 9. Stomachprobe according to least one of the foregoing claims, characterized inthat adjustment of pressure is made through a fluid column constitutedby the medium.
 10. Stomach probe according to any of the foregoingclaims, characterized in that the inner cavity of the tampon-bladder(16) is connected by a large-diameter channel with an equalizing device(11).
 11. Stomach probe according to at least one of the foregoingclaims, characterized in that a marker is placed on the tampon-bladder(16).
 12. Stomach probe according to at least one of the foregoingclaims, characterized in that the tampon-bladder (16, 16′) is part of aclosed fluid system.
 13. Stomach probe according to claim 12 ,characterized in that by at least one Reservoir (23) at least one innercavity is formed, which in at least one sector is closed off by aflexible or elastic wall.
 14. Stomach probe according to at least one ofthe foregoing claims, characterized in that the tampon-bladder (16′) isprovided in at least one sector with a wall (21) displaying folds (22).15. Stomach probe according to at least one of the foregoing claims,characterized in that a pressure-measuring probe (32) is located withits measuring end (27′) in the tampon-bladder (16, 16′) or in a cavitycommunicating with the inner cavity of the tampon-bladder, for examplein the inner cavity of the outer lumen (18).
 16. Stomach probe accordingto claim 15 , characterized in that the probe (32) is formed by ameasuring-tube (27) which forms the measuring end at its open end and atthe other end, extracorporeally, incorporates a pressure-sensor orpressure-transducer (28), and that the measuring-tube (27) is filledwith the fluid in such a way that the whole channel of themeasuring-tube between the two ends (27′, 27″) is filled with the fluid.